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FDA Guidance for Industry: ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information

Origin/Publisher:

Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852

Document Type:
Guidance for Industry
Content:
This guidance is intended to assist applicants with the submission of ANDAs when a drug substance exists in polymorphic forms

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